BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2222972 · Received August 10, 2011

    Report

    Report Number
    2242352-2011-01104
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CAN NOT BE PERFORMED. WE WILL, HOWEVER, CONTINUE TO MONITOR AND TREND THIS TYPE OF EVENT TO ENSURE THAT THERE IS NO COMPROMISE TO QUALITY. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NON CONFORMANCE ISSUE(S) WITH THIS PRODUCTION LOT. ITEMS MARKED 'NI" ARE UNKNOWN TO USA T THIS TIME. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPORO 2 WIRE ON THE INSIDE OF THE JAW BECAME SEPARATED FROM THE JAW ITSELF. THE DEVICE WAS ALSO SHUTTING OFF IN THE MIDDLE OF BRANCH LIGATION. THIS HAPPENED SEVERAL TIMES BUT THE EXACT NUMBER IS UNKNOWN. A REPLACEMENT UNIT WAS USED TO COMPLETE EACH PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. PRODUCTS ARE NOT RETURNING. THE EVENT DATE AND LOT NUMBERS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI